Job Description

Position Summary

The Regulatory Affairs Specialist is responsible for ensuring DemeTECH Corporation complies with the regulatory requirements of FDA, ISO, EU MDR, Health Canada, CFDA, and other applicable authorities. This role leads pre-market and post-market regulatory activities including 510(k) and Technical Documentation submissions, PMS reporting, UDI compliance, and sterilization documentation. The position is also responsible for cross-functional regulatory guidance, audit preparation, and international market registration.

Key Responsibilities

• Prepare and submit 510(k) pre-market notifications and CE Mark Technical Documentation.
• Maintain and update Design History Files (DHFs), Risk Management Files (RMFs), and UDI/GUDID records.
• Support development of Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), and Vigilance/MD/NC Reporting.
• Monitor global regulatory trends and communicate implications for product development and lifecycle management.
• Collaborate with R&D, Quality, Manufacturing, and Clinical teams to ensure regulatory compliance of product claims, labeling, and instructions for use.
• Interface with FDA, Notified Bodies, and international competent authorities during audits, Q-Subs, and pre-submission meetings.
• Support sterilization (ISO 11135), biocompatibility (ISO 10993), and shelf life validation documentation.
• Manage international registrations by compiling Certificates to Foreign Governments (CFGs), declarations, and dossiers.
• Track regulatory submissions, approvals, and country-specific licensing renewals.

Minimum Education Requirements

• Bachelor’s Degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field (required).
• Preferred: Master’s Degree or RAC certification (US/EU) or equivalent.

Required Competencies & Qualifications

• 3+ years of experience in Regulatory Affairs within medical devices (Class II preferred).
• Working knowledge of 21 CFR 807, 820, 803, ISO 13485:2016, MDR 2017/745, and ISO 14971.
• Experience preparing 510(k) submissions and EU MDR Technical Files.
• Experience with UDI submissions and FDA GUDID database.
• Knowledge of sterilization validations (EO, ISO 11135) and biological safety evaluations (ISO 10993 series).
• Ability to interpret product standards, FDA guidance documents, and harmonized EN standards.
• Strong skills in technical writing, document control, and regulatory project management.
• Proficiency in regulatory software systems and electronic submission platforms (e.g., eSTAR, ESG).
• Demonstrated ability to manage timelines, cross-functional input, and stakeholder communication.
• Strong attention to detail, with a proactive mindset in identifying regulatory risks and opportunities.

Desirable Attributes

• Regulatory experience in wound closure, barbed sutures, or implantable materials (e.g., PGA-PCL, PDO).
• Understanding of clinical evaluation reports (CERs), post-market clinical follow-up (PMCF), and clinical literature review methodologies.
• Experience interacting with Notified Bodies, Authorized Representatives, and in-country agents.

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